MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-07 for TUBING, INSUFFLATION W/ .3 MIC FILT/ STRYKER ADA 28-0211 manufactured by S.l.r. Km7, Autopista Joaquin Balaguer.
[17589599]
Customer reported an alarm that indicated there was a leak in the line. When the customer was contacted for additional information, it was reported that the "tube was obstructed at the filter".
Patient Sequence No: 1, Text Type: D, B5
[17735197]
This report is being filed due to a retrospective review of complaints. This complaint has been re-opened for further investigation. A supplemental report will be filed if further investigation provides information which changes the content of this report. The original root cause was determined to be migration of the plasticizer into the filter housing. It was determined to change the filter housing. It was determined to change the filter material to a polycarbonate material which is stronger, higher impact, and more chemical resistant. It is also less affected by temperature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2015-00007 |
| MDR Report Key | 4759440 |
| Report Source | 06 |
| Date Received | 2015-05-07 |
| Date of Report | 2015-04-30 |
| Date of Event | 2012-02-16 |
| Date Facility Aware | 2012-02-16 |
| Report Date | 2015-04-30 |
| Date Mfgr Received | 2012-02-16 |
| Device Manufacturer Date | 2011-11-07 |
| Date Added to Maude | 2015-06-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626157 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2113-2013 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUBING, INSUFFLATION W/ .3 MIC FILT/ STRYKER ADA |
| Generic Name | INSUFFLATION TUBING, TBING W/ FILTER |
| Product Code | NKC |
| Date Received | 2015-05-07 |
| Returned To Mfg | 2012-02-27 |
| Catalog Number | 28-0211 |
| Lot Number | 25962556 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S.L.R. KM7, AUTOPISTA JOAQUIN BALAGUER |
| Manufacturer Address | PISANO FREE ZONE, BLDG. 49 SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-07 |